Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Materialise Dental NV · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
162 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120733 | SIMPLANT GO | Materialise Dental NV | 2012-07-05 | 118 | 0 |
| K113739 | SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM | Materialise Dental NV | 2012-05-30 | 162 | 0 |
| K112679 | SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM | Materialise Dental NV | 2012-02-22 | 161 | 0 |
| K110300 | SIMPLANT 2011 | Materialise Dental NV | 2011-07-01 | 149 | 0 |
| K081402 | SIMPLANT ORTHO ; VISTADENT 3D | Materialise Dental NV | 2008-07-18 | 60 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda